Trial | NCT03115073  Report issue

Title

ProF-001_Phase IIa
A Phase IIa Randomized, Active-controlled, Double-blind, Dose-escalation Study in Patients With Vulvovaginal Candidiasis to Evaluate Dose Response Relationship of Clinical Efficacy, Safety and Tolerability of Topically Administered ProF-001

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluconazole ...

  • Study Participants

    84
This is a multi-center, randomized, prospective, active-controlled, double-blind, dose-escalation study comparing dose response of clinical efficacy, safety, local tolerability of three different doses of ProF-001/Candiplus® (Candiplus® 0.2%, Candiplus® with 0.3%, Candiplus® with 0.4%) to 1% clotrimazole vaginal cream.

Patients with acute episode of vulvovaginal candidiasis (VVC) will be randomized to receive a daily dose of either 5 ml (intravaginal) of Candiplus® at three different doses for the first 3 days and 2.5 ml for the remaining 3 days or 5 ml (intravaginal) application of 1% clotrimazole cream over the first 3 days and 2.5 ml for the remaining 3 days according to the following scheme (with each application 2 cm of cream will be applied to the vulvar region):

Cohort 1: Candiplus® 0.2% versus clotrimazole mono Cohort 2: Candiplus® 0.3% versus clotrimazole mono Cohort 3: Candiplus® 0.4% versus clotrimazole mono Randomization into the cohorts will occur consecutively from the lowest dose to the highest dose, i.e. patients will be randomized first in cohort 1 and finally in cohort 3.

The proposed study is - after a pilot study to assess critical pharmacokinetic data - the second study within a clinical trial program with the objective to develop a new combination therapy for the treatment of vulvovaginal candidiasis.

The new combination consists of two registered drug substances.
Study Started
Apr 04
2017
Primary Completion
Jul 30
2018
Study Completion
Jul 30
2018
Last Update
Mar 14
2019

Drug Candiplus

Administration of Candiplus

Drug Clotrimazole

Administration of Clotrimazole

0,2% Candiplus Experimental

Candiplus® 0.2%

0,3% Candiplus Experimental

Candiplus® 0.3%

0,4% Candiplus Experimental

Candiplus® 0.4%

Clotri mono Active Comparator

Clotrimazole mono

Criteria 

Inclusion Criteria:

Premenopausal female patients ≥ 18 years old

Patients suffering from an acute episode of vulvovaginal candidiasis, characterized by:

Positive vaginal smear (native, KOH) for budding yeasts and/or fungal (pseudo-) hyphae, normal or intermediate flora (G I and G II)
Positive clinical symptoms (itching, burning, irritation, edema, erythema, excoriations), with a subjective symptom score of at least 3 (0=absent, 1=mild, 2=moderate, and 3=severe), with score being at least moderate for at least 1 subjective symptom and itching being present, and a total sign and symptom score of at least 4
Readiness for sexual abstinence from start of treatment until test of cure (TOC) - visit
Sufficient knowledge of German language to understand trial instructions and rating scales, and ability to comply with treatment
Written informed consent prior to enrolment

Exclusion Criteria:

Known hypersensitivity to any ingredient of the investigational medicinal product
Pregnancy or breast feeding at time of screening
Menstrual bleeding (spotting is not an exclusion criterion) during the first three days of treatment
Acute cystitis
Patients with clinical signs of other infectious causes of vulvovaginitis: bacterial vaginosis (GIII), trichomonas vaginalis, herpes simplex genitalis
Treatment with antimycotics (systemic or vaginal) within 7 days of randomization
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
Patients with other clinical gynecological abnormalities, such as infections of the upper urogenital tract (pelvic inflammatory disease, adnexitis)
Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response (e.g. Lichen sclerosus, neuropathic pain)
Subjects who will be under treatment or surgery for gynecological pathologies during the study period, i.e, cervical intraepithelial neoplasia, cervical carcinoma, other neoplasms
Known alcohol, drug or medication abuse
Any clinically relevant concomitant condition that could compromise the objectives of this study and/ or the patient's compliance (eg. known immune deficiency syndrome with clinical relevance at time of screening)
Participation in another interventional clinical trial within the last 30 days
Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
No Results Posted